The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients
Recruiting · NCT06428422 · Interventional (participants receive a specific treatment) · Lead sponsor: Necmettin Erbakan University
View the official record on ClinicalTrials.gov →Interventions studied
Bifidobacterium animalis subsp. lactis Bl-04Plasebo
What this trial is about
The aim of this study is to evaluate the effect of a probiotic supplement containing Bifidobacterium animalis lactis BL-04 on the clinical effectiveness of immunotherapy in patients diagnosed with metastatic non-small cell lung cancer who are receiving immunotherapy.
Who can take part
Age range
19 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Volunteering to participate in the study.
- Histologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC).
- Patients must be in an advanced stage (incurable with surgery or radiotherapy) or have metastatic disease (Stage IV).
- Male or female patients aged \>18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status less than 2.
- Laboratory findings must confirm adequate bone marrow function, indicated by:
- White Blood Cell (WBC) count \> 2,000/mm³, Neutrophil count \> 1,500/mm³,Platelet count \> 100,000/mm³
Exclusion criteria
- Previously received treatment with any of the following antibody blockers: anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4.
- Currently taking probiotic supplements or consuming probiotic bacteria-supported yogurt and similar food supplements.
- Antibiotic utilization within the past month
- Active interstitial lung disease or a history of interstitial lung disease requiring systemic steroid treatment.
- A condition requiring systemic corticosteroids (greater than 10 mg of prednisone daily or equivalent) or who have received immunosuppressive treatment within 14 days prior to the first dose of the study.
- Presence of uncontrolled adrenal insufficiency.
- Pregnancy or breastfeeding.
- Severe congestive heart failure (Class III or higher according to the New York Heart Association Functional Classification) or a history of myocarditis.
- Uncontrolled cardiac arrhythmia that developed within six months prior to the start of the study.
Where it is running
1 location listed.
- Necmettin Erbakan University - Konya, Turkey (Türkiye)